Ensartinib for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II Pediatric MATCH treatment trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or does not respond to treatment (refractory) and may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop some medications. You cannot take other anti-cancer agents, investigational drugs, or strong CYP3A4 inducers/inhibitors. If you're on corticosteroids, you must be on a stable or decreasing dose for at least 7 days before enrolling. Anti-GVHD agents post-transplant are also not allowed. Check with the study team for specific guidance on your medications.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications before enrolling. You cannot be on other anti-cancer agents, investigational drugs, or strong inducers or inhibitors of CYP3A4. If you're on corticosteroids, you need to be on a stable or decreasing dose for at least 7 days before enrolling.
What safety data exists for Ensartinib (also known as Ensacove, X-396, Ensartinib Hydrochloride) for cancer treatment?
The provided research does not contain specific safety data for Ensartinib or its other names. It focuses on other cancer treatments like avapritinib, encorafenib, lenvatinib, regorafenib, and sorafenib, discussing their adverse events and management. To find safety data for Ensartinib, further research specifically targeting this drug is needed.12345
Is the drug Ensartinib a promising treatment for cancer?
What data supports the idea that Ensartinib for Cancer is an effective treatment?
The available research does not provide any data on Ensartinib for Cancer. Instead, it focuses on another drug, Sorafenib, which is used for treating different types of cancer, such as renal cell carcinoma and breast cancer. Sorafenib has shown effectiveness in prolonging the time patients live without their cancer getting worse, compared to a placebo. However, this information does not relate to Ensartinib, so we cannot determine its effectiveness from the provided data.1112131415
Who Is on the Research Team?
Meredith S Irwin
Principal Investigator
Children's Oncology Group
Are You a Good Fit for This Trial?
This trial is for children and young adults up to 21 years old with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have specific genetic changes (ALK or ROS1) and haven't responded to previous treatments. Participants need normal organ function, must be able to swallow capsules, and can't have had ensartinib before.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ensartinib orally once daily on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Long-term follow-up
Participants are monitored for progression-free survival and changes in tumor genomic profile
What Are the Treatments Tested in This Trial?
Interventions
- Ensartinib
Ensartinib is already approved in United States for the following indications:
- ALK-positive non-small cell lung cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Children's Oncology Group
Collaborator